510(k) Report

Devices descending from K152457

145 later devices reach CD HORIZON Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+1K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+1K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+1K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+1K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.201645—
+1K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+1K153442CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with…Medtronic Sofamor Danek USA, Inc.201684—
+1K153589CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.201610—
+2K252322SIros-X SystemGenesys Spine20250—
+2K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+2K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+2K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+2K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+2K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+2K223494CD Horizon Spinal SystemMedtronic202317—
+2K221244CD Horizon™ Spinal SystemMedtronic202220—
+2K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+2K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+2K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+2K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+2K202328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.20200—
+2K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+2K181139OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20188—
+2K172115Navigated Instrument SystemOrthofix, Inc.20184—
+2K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.2017165
+2K162921Navigated Instrument SystemOrthofix, Inc.20175—
+2K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.20162—
+2K161842Overwatch Spine SystemAmendia, Inc.201661
+2K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+3K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+3K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+3K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+3K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20260—
+3K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.20260—
+3K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+3K253331PressON Spinal Fixation SystemNexus Spine20250—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+3K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+3K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+3K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+3K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+3K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+3K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+3K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+3K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+3K232141CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System…Medtronic Sofamor Danek USA, Inc.20231—
+3K231280CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X…CarboFix Orthopedics, Ltd.20234—
+3K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+3K223764INFINITY OCT SystemMedtronic Sofamor Danek USA, Inc.20230—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K220810Infinity™ OCT System and PASS OCT Spinal SystemMedicrea International20220—
+3K210449Infinity™ OCT System, PASS OCT® Spinal SystemMedtronic20213—
+3K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188—
+3K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+3K173126Arisstos™ Spinal SystemIngenium Spine20171—
+3K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+3K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+4K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+4K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+4K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.20260—
+4K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+4K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+4K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+4K241258Ingenix Spinal SystemIngenium Spine20240—
+4K233078Posterior Cervical Spine SystemDouble Medical Technology, Inc.20231—
+4K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+4K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+4K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+4K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+4K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+4K192646SYMPHONY™ OCT SystemMedos International SARL20202—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+4K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+4K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+4K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+5K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—